QA Investigator II

Summary: BioPharma Consulting JAD Group is seeking a highly motivated and detail-oriented individual to join our quality assurance team as a QA Investigator II. The QA Investigator II is responsible for supporting and leading deviation investigations to ensure accurate, thorough, and on time completion. The incumbent applies systematic and analytical root cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation. Skills and experience must include previous investigation skills that require multi-departmental stakeholder engagement.

Functions

Work collaboratively with staff and management of site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.

Participate and lead investigations for deviations and incidents.

Participate in complex and/or high impact investigations, including those with product impact. Identifies root and contributing causes.

Conduct thorough investigations into quality issues and deviations in a timely manner.

Identify root causes of quality issues and deviations and develop effective corrective and preventive actions.

Collaborate with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to gather necessary information and implement corrective actions.

Ensures required management and Quality approvals on final investigations while satisfying established due dates.

Facilitates corrective and preventive action agreement with stakeholders.

Facilitates internal sharing of investigational findings and risk knowledge.

Contributes to metrics related to investigation process and CAPA effectiveness.

Support client due diligence and Quality audits as well as regulatory inspections.

Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

All other duties as assigned

Required Skills & Abilities

Experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques.

Facilitation skills and proven record to effectively lead cross-functional teams.

Technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.

Ability to interpret technical information and documentation used for operations and production activities.

Experience in management of diverse stakeholders with strong interpersonal/influencing skills.

Experience in performance improvement with basis in Human and Organizational Performance principles.

Practical knowledge and application of cGMP, cGLP, EMEA, compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.

Proficient in Microsoft Excel, Word and PowerPoint.

Requirements

Qualifications:

Bachelor’s degree with 2+ years of related experience; OR

Associates degree and/or 3+ years of related experience

At least 1 year of cGMP experience

Preferred

Degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline.

Six Sigma Black Belt

Kepner-Tregoe Methods (5 Analytical Techniques SA, PA, DA, PPA, POA)

Conger-Elsea Methods (HBT/DA, Logic FT, E&CF chart)

MEEPS

Applied Human and Operational Performance (HOP)